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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
399 jefferson road
parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS009
Date Received03/13/1997
Decision Date09/24/1999
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 00M-0901
Advisory Committee Orthopedic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for SpinalPak Bone Growth Stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling